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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02947152




Registration number
NCT02947152
Ethics application status
Date submitted
12/09/2016
Date registered
27/10/2016

Titles & IDs
Public title
HKT288 in Solid Tumors, Including Epithelial Ovarian Cancer and Renal Cell Carcinoma
Scientific title
A Phase I, Multicenter, Open-label Dose Escalation and Expansion Study of HKT288, Administered Intravenously in Adult Patients With Advanced Solid Tumors, Including Epithelial Ovarian Cancer and Renal Cell Carcinoma
Secondary ID [1] 0 0
CHKT288X2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial Ovarian Cancer 0 0
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HKT288

Experimental: Dose escalation part - Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer) and clear cell or papillary renal cell carcinoma

Experimental: Dose expansion part (RCC arm) - Includes patients with clear cell or papillary renal cell carcinoma

Experimental: Dose expansion part (ovarian cancer arm) - Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer)


Treatment: Drugs: HKT288
Cadherin-6-targeting antibody-drug conjugate for intravenous administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose limiting toxicities (DLTs) in the DLT evaluation period
Timepoint [1] 0 0
evaluation period is 21 days
Primary outcome [2] 0 0
Safety assessed by overall incidence of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [2] 0 0
Until 105 days after last dose of study treatment (=average of approximately 6 months after first dose)
Primary outcome [3] 0 0
Tolerability as assessed by numbers of dose changes or interruptions
Timepoint [3] 0 0
Until last dose of study treatment (=average of approximately 6 months after first dose)
Primary outcome [4] 0 0
Safety assessed by severity of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [4] 0 0
Until 105 days after last dose of study treatment (=average of approximately 6 months after first dose)
Secondary outcome [1] 0 0
Concentration vs. time profiles of total antibody (tAb)
Timepoint [1] 0 0
On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose). 1 cycle is 21 days, increases to 28 days if there is a dose delay of 7 days for the start of next dose
Secondary outcome [2] 0 0
Objective response rate
Timepoint [2] 0 0
every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)
Secondary outcome [3] 0 0
Duration of response
Timepoint [3] 0 0
every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)
Secondary outcome [4] 0 0
Progression-free survival
Timepoint [4] 0 0
every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)
Secondary outcome [5] 0 0
Disease Control Rate
Timepoint [5] 0 0
At 6 months on treatment
Secondary outcome [6] 0 0
Best overall response
Timepoint [6] 0 0
every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)
Secondary outcome [7] 0 0
Presence of anti-HKT288 antibodies.
Timepoint [7] 0 0
On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
Secondary outcome [8] 0 0
CDH6 expression level
Timepoint [8] 0 0
3 months
Secondary outcome [9] 0 0
Pharmacokinetics (PK) parameter (AUC) for HKT288
Timepoint [9] 0 0
On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
Secondary outcome [10] 0 0
PK parameter (Cmax) for HKT288
Timepoint [10] 0 0
On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
Secondary outcome [11] 0 0
PK parameter (Tmax) for HKT288
Timepoint [11] 0 0
On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
Secondary outcome [12] 0 0
PK parameters (half-life) for HKT288
Timepoint [12] 0 0
On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)

Eligibility
Key inclusion criteria
Main

* Advanced (metastatic or locally advanced) serous epithelial ovarian, serous fallopian tubal or serous primary peritoneal cancer or advanced clear cell or papillary renal cell carcinoma who have received or are intolerant to all therapy known to confer clinical benefit for their disease, as determined by the investigator.
* Tumor sample is available for retrospective CDH6 expression testing
* Eastern Cooperative Oncology Group (ECOG) Performance status =2

Main
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient has central nervous system metastatic involvement. Patients with previously treated CNS metastases are also excluded.
* Patient with any active or chronic corneal disorders
* Patients with monocular vision or have media opacities or any other condition that precludes monitoring of the retina or fundus.
* Patients with a history of serious allergic reactions
* Patients with QTcF >470 msec at screening ECG or congenital long QT syndrome
* Any prior history of treatment with maytansine (DM1 or DM4)-based ADC
* Patient have received anti-cancer therapies within the following time frames prior to the first dose of study treatment:

* Conventional cytotoxic chemotherapy: =4 weeks (= 6 weeks for nitrosoureas and mitomycin-C)
* Biologic therapy (e.g., antibodies): =4 weeks
* Non-cytotoxic small molecule therapeutics: =5 half-lives or =2 weeks (whichever is longer)
* Other investigational agents: =4 weeks
* Radiation therapy (except for localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture): =4 weeks
* Radiation therapy (localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture) =2 weeks
* Major surgery: =2 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/09/2017
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Japan
State/province [3] 0 0
Aichi
Country [4] 0 0
Spain
State/province [4] 0 0
Catalunya
Country [5] 0 0
Switzerland
State/province [5] 0 0
Locarno

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02947152